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The Debate Over New Medications: What's Best for Your Patients?
by Richard Sherer
Geriatric Times May/June 2003 Vol. IV Issue 3
The results of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) published in the Dec. 18, 2002, issue of JAMA found, "Thiazide-type diuretics ... are unsurpassed in lowering [blood pressure], reducing clinical events, and tolerability, and ... are less costly." This conclusion has shifted some of the focus of the debate from high pharmaceutical costs to the issue of efficacy.
Sponsored by the National Heart, Lung, and Blood Institute, ALLHAT was a randomized, double-blind, multicenter, practice-based clinical trial. It was designed to determine whether the occurrence of coronary heart disease or nonfatal myocardial infarction is lower for high-risk hypertensive patients treated with a calcium channel blocker, an angiotensin-converting enzyme (ACE) inhibitor or an α-blocker compared with diuretic treatment.
The ALLHAT results have been contradicted by the results of the Second Australian National Blood Pressure Study, which were published in the Feb. 13 issue of The New England Journal of Medicine. This study found an ACE inhibitor more effective than a diuretic, leading most observers to call for more research.
The ALLHAT findings did raise the question of whether some older or less-promoted medications may be useful in treating some conditions.
"I think it is a valid question," Ken Brummel-Smith, M.D., chair of the department of geriatrics at the Florida State University School of Medicine and chair of the board of the American Geriatrics Society, told Geriatric Times. "This particular study was very important because it showed something important in general in the treatment of systolic hypertension, which is more common in older people: that it is most responsive to cheap dyazide-type diuretics."
The dispute over the relative effectiveness of ACE inhibitors and diuretics is only the tip of a very large iceberg that ultimately affects consumers' pockets. Virtually no information is available on the comparative efficacy of new drugs versus the medications they replace, yet their manufacturers spend large sums of money on marketing every year, much of it directed toward consumers.
"There are not a lot of head-to-head trials between cheap, older drugs and the new ones," said Brummel-Smith. "People don't usually compare them. New drugs are tested against a placebo, which is an important step initially. However, there is limited interest by the drug companies in testing new drugs against older ones, especially if the new ones offer only marginal benefits. Those kinds of tests are few and far between. It's an important reason why the government should continue to fund these types of studies."
Pharmaceutical spending increased by approximately 25% a year between 1996 and 1999, according to a study by Brandeis University and PCS Health Systems. The retail price of prescription drugs more than doubled between 1991 and 2001 and continues to climb. For seniors with no prescription drug benefit and limited incomes, that kind of increase in one segment of the budget usually means skimping on something else. Studies also have shown that patients will take reduced dosages of a prescribed drug in an effort to stretch their supply, and many patients never bother to fill prescriptions because of the costs.
"Physicians are generally unaware of what brand name prescription drugs cost," Timothy R. Covington, M.S., Pharm.D., executive director of the Managed Care Institute at the McWhorter School of Pharmacy, told GT. "When given the opportunity to learn or utilize cost-comparison resources, they generally put very little energy into the process. This creates tremendous problems for the uninsured, underinsured and Medicare recipient with no outpatient drug benefit."
Covington said there are generic or low-priced alternatives for a variety of prescription medications. Brummel-Smith pointed out that over-the-counter medications may provide relief for a great many patients. "A large percentage of patients with osteoarthritis, for example, do very well with Tylenol [acetaminophen]. Compared with more expensive over-the-counter drugs, or even very expensive products like Vioxx [rofecoxib], most often people get better with regular doses of acetaminophen.
"Cost is rarely ever considered in a drug study because people in a study get drugs for free," he said. "Say you had a drug that was shown to be 50% better than a cheap drug but cost three times more than the cheap drug. In a study, the patients would do 50% better, so the report says Drug B is 50% better than the standard. What is not mentioned is that it costs three times or 10 times more, or how many patients actually stay on the drug or take it in the appropriate way because of cost. Do 50% more people in real-life situations take it? That factor also is not studied very often.
"There have been studies that show there are price points that people are unwilling to go above. So they don't take their prescriptions or they take them in another way. In a large number of cases, they don't tell their doctor that they're not taking their medication, they don't tell their doctor that they are halving the dosage. Then, when they're not showing any improvement, a second drug is put on and they don't get better with that, either."
Physicians are beginning to understand the scope of the problem. The Long Island, N.Y., newspaper Newsday recently reported that physicians are supplying elderly patients with sample drugs to help defray out-of-pocket costs. One source said that the practice amounted to "the pharmaceutical equivalent of running from soup kitchen to soup kitchen for dinner."
According to Brummel-Smith, medical meetings are beginning to look at prescription alternatives. "We're beginning to see an increasing understanding of use of nonprescription or complementary medicine," he said. "It is still very limited on the part of M.D.s and D.O.s. But we are hearing more about alternatives at some of the meetings. For example, in treating dementia with the use of vitamin E or Ginkgo [biloba]. Sure, it's controversial, but there's also controversy about the prescription drugs. There need to be more studies."
Many new drugs, as it turns out, are not significantly better than the ones they are meant to replace. A study by the National Institute for Health Care Management Foundation (NIHCM) found that two-thirds of the prescription drugs approved by the U.S. Food and Drug Administration between 1989 and 2000 were modified versions of existing medicines or identical to drugs already on the market. In addition, only one-third of newly approved drugs were based on new molecules that treat diseases in novel ways, and "only 15% of drugs approved during that period both used new chemical compounds as their active ingredients and were deemed by the FDA to provide a significant improvement over existing medicines."
On a per-prescription basis, new drugs are significantly more expensive. The NIHCM study found that "priority-rated new molecular entities cost an average of $91.20 per prescription" in 2000, compared with $37.20 for drugs approved prior to 1995. For drugs that offered only incremental changes from older versions, the per-prescription price was $65.07.
The government now is considering the use of managed care organizations to help administer Medicare in the expectation that private-sector techniques will be better suited to controlling the costs of a drug benefit program for seniors. While managed care organizations have made some attempt to limit the proliferation of high-priced drugs through the use of formularies, Covington had doubts that they will be very effective in shifting prescribers' tendencies toward lower-priced alternatives.
"Managed care organizations foster generic drug utilization up to a point, but they will not generally go as far as they could with it because it would impair a very rich source of revenue for them, which is rebate revenue off of brand name drug use," he said.
Brummel-Smith also saw a problem arising from the expanded use of direct-to-consumer advertising by drug manufacturers. "It is very difficult for doctors who are in a time crunch to go through much of a discussion every time a patient comes in and says, 'I've seen this drug on TV.' Usually the doctor just says, 'OK. I'll give it to you.'
"As I see it, that's one potential danger of a having a prescription drug benefit," he added. "One benefit of not having it is that people use [fewer] drugs. The use of drugs and the potential for interactions would be greater with a drug benefit. I'm not against a prescription drug benefit, but I think other things should happen, too, like placing limits on direct-to-consumer advertising and encouraging more head-to-head testing before marketing."
